PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling.

Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one dose of IV Activase placebo and one dose of oral aspirin 325 mg.

Treatment with heparin within past 48 hrs AND an activated partical thromboplasting time outside normal

Blood glucose < 50 mg/dL

International normalized ratio > 1.7

Platelet count < 100,000/cm3

Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban,edoxaban) within the last 48 hrs

Allergic reaction to study drug or aspirin

Females of childbearing age who are known to be pregnant and/or lactating

Inability to swallow aspirin or aspirin placebo capsule

Other serious illness that would confound the clinical outcome at 90 days

Current or recent (within 3 months) participation in another investigational drug treatment protocol

Anticipated inability to obtain 3-month follow-up assessments

Previous enrollment in PRISMS

Any other condition deemed by the investigator that would pose hazard to the patient with alteplase treatment

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072226